QUALITY CONTROL AND MODEL DEVELOPMENT IN RODENTS AND TUMOR CELLS
NIH GUIDE, Volume 22, Number 5, February 5, 1993
RFP AVAILABLE: NCI-CM-47000-28
P.T. 34
Keywords:
Disease Model
Animal Breed. & Facil., Scientific
Cell Lines
National Cancer Institute
The Development Therapeutics Program (DTP), Division of Cancer
Treatment, (DCT), National Cancer Institute (NCI), is interested in
organizations that have the necessary experience, scientific and
technical personnel, and facilities to evaluate the activity of
potential anti-neoplastic compounds against in vitro cell lines and
in vivo tumor systems. Maintenance of the integrity and reliability
of the in vivo tumor systems is necessarily dependent upon rigorous
quality control of the tumors and host animals. Further, kinetic
data obtained during tumor analyses are used to assist in drug
treatment scheduling and interpretation of drug testing results.
This project is required so that variations in laboratory data can be
identified and analyzed as to cause, e.g., animal source, tumor
source, or laboratory technique. In addition, in vivo testing
protocols must be established for candidate tumor models from the
human tumor cell disease-oriented screening panel to provide the
necessary follow-up of active materials identified for development as
candidates for possible clinical trial.
The Contractor will be required to perform the following specific
tasks: perform tumor cell kinetic studies, including determination
of doubling times and labeling indices for all tumor lines available
for use in the in vivo testing program; develop working protocols
suitable for drug testing using tumor models designed by the NCI
Project Officer; test both standard agents and new agents identified
in the in vitro prescreen in in vivo protocols developed for DTP;
evaluate the response of host animals from all animal supply sources
to appropriate tumor lines; evaluate the drug response and growth
characteristics of tumors routinely used in the Program; evaluate the
efficacy of current and new COPs for maintaining pathogen-free tumor
lines and/or animals prior to their use in the Program; prepare and
maintain in vitro tumor cell cultures in support of the in vivo
program; and develop new or modify existing protocols with the goal
of establishing a minimal challenge model for use in early in vivo
screening of anticancer drug candidates. The government will
designate and supply the agents to be tested. The successful offeror
will be expected to provide all equipment, solvents, reagents, and
animal facilities needed to conduct this type of work.
It is expected that one cost-reimbursement contract, completion form,
will be awarded as a result of the solicitation. This contract is
planned to be incrementally funded over a five-year period. The
proposed contract project represents a recompetition of Southern
Research Institute, Contract N01-CM-97553.
This project requires that the following restriction be applied:
"The NCI signs legally binding agreements with certain suppliers
(often pharmaceutical or chemical companies), these agreements state
that all information submitted by the supplier will be held
confidential. Structural characteristics may have to be revealed in
the event that reformulation, solubility, or preliminary
pharmacokinetic studies are done to assure/improve proper dosing
regimens and treatment schedules. Pharmaceutical or chemical
companies could obtain valuable data on new leads through this
mechanism. Therefore, in order to honor the confidentiality
agreements made with suppliers, the NCI believes that such
information on compounds cannot be disclosed to potential competitors
of the supplier. Thus, pharmaceutical and chemical companies must be
excluded from competition on the above referenced RFP. For purposes
of this exclusion, a pharmaceutical or chemical company is defined as
"an organization that manufactures and/or sells drugs and chemicals
to the general public for profit."
All responsible sources may submit a proposal that will be considered
by the NCI. This announcement is not a request for proposal (RFP).
RFP NCI-CM-47000-28 will be available on or about February 1, 1993,
with a response date of March 18, 1993, for the receipt of proposals.
INQUIRIES
Copies of the RFP may be obtained by written request to:
Ms. Carolyn Barker
Research Contracts Branch
Treatment Contracts Section
National Cancer Institute
Executive Plaza South, Room 603
Bethesda, MD 20892
.